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1.
JAMA Netw Open ; 7(4): e244246, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38578641

RESUMO

Importance: Drug shortages are a chronic and worsening issue that compromises patient safety. Despite the destabilizing impact of the COVID-19 pandemic on pharmaceutical production, it remains unclear whether issues affecting the drug supply chain were more likely to result in meaningful shortages during the pandemic. Objective: To estimate the proportion of supply chain issue reports associated with drug shortages overall and with the COVID-19 pandemic. Design, Setting, and Participants: This longitudinal cross-sectional study used data from the IQVIA Multinational Integrated Data Analysis database, comprising more than 85% of drug purchases by US pharmacies from wholesalers and manufacturers, from 2017 to 2021. Data were analyzed from January to May 2023. Exposure: Presence of a supply chain issue report to the US Food and Drug Administration or the American Society of Health-Systems Pharmacists (ASHP). Main Outcomes and Measures: The main outcome was drug shortage, defined as at least 33% decrease in units purchased within 6 months of a supply chain issue report. Random-effects logistic regression models compared the marginal odds of shortages for drugs with vs without reports. Interaction terms assessed heterogeneity prior to vs during the COVID-19 pandemic and by drug characteristics (formulation, age, essential medicine status, clinician- vs self-administered, sales volume, and number of manufacturers). Results: A total of 571 drugs exposed to 731 supply chain issue reports were matched to 7296 comparison medications with no reports. After adjusting for drug characteristics, 13.7% (95% CI, 10.4%-17.8%) of supply chain issue reports were associated with subsequent drug shortages vs 4.1% (95% CI, 3.6%-4.8%) of comparators (marginal odds ratio [mOR], 3.7 [95% CI, 2.6-5.1]). Shortages increased among both drugs with and without reports in February to April 2020 (34.2% of drugs with supply chain issue reports and 9.5% of comparison drugs; mOR, 4.9 [95% CI, 2.1-11.6]), and then decreased after May 2020 (9.8% of drugs with reports and 3.6% of comparison drugs; mOR, 2.9 [95% CI, 1.6-5.3]). Significant associations were identified by formulation (parenteral mOR, 1.9 [95% CI, 1.1-3.2] vs oral mOR, 5.4 [95% CI, 3.3-8.8]; P for interaction = .008), WHO essential medicine status (essential mOR, 2.2 [95% CI, 1.3-5.2] vs nonessential mOR, 4.6 [95% CI, 3.2-6.7]; P = .02), and for brand-name vs generic status (brand-name mOR, 8.1 [95% CI, 4.0-16.0] vs generic mOR, 2.4 [95% CI, 1.7-3.6]; P = .002). Conclusions and Relevance: In this national cross-sectional study, supply chain issues associated with drug shortages increased at the beginning of the COVID-19 pandemic. Ongoing policy work is needed to protect US drug supplies from future shocks and to prioritize clinically valuable drugs at greatest shortage risk.


Assuntos
COVID-19 , Humanos , Estados Unidos/epidemiologia , COVID-19/epidemiologia , Pandemias , Estudos Transversais , Preparações Farmacêuticas , Medicamentos Genéricos
2.
Pharmacoepidemiol Drug Saf ; 33(4): e5777, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38511239

RESUMO

BACKGROUND: Valsartan is commonly used for cardiac conditions. In 2018, the Food and Drug Administration recalled generic valsartan due to the detection of impurities. Our objective was to determine if heart failure patients receiving valsartan at the recall date had a greater likelihood of unfavorable outcomes than patients using comparable antihypertensives. METHODS: We conducted a cohort study of Optum's de-identified Clinformatics® Datamart (July 2017-January 2019). Heart failure patients with commercial or Medicare Advantage insurance who received valsartan were compared to persons who received non-recalled angiotensin receptor blockers (ARBs) and angiotensin converting enzyme-inhibitors (ACE-Is) for 1 year prior and including the recall date. Outcomes included a composite for all-cause hospitalization, emergency department (ED), and urgent care (UC) use and a measure of cardiac events which included hospitalizations for acute myocardial infarction and hospitalizations/ED/UC visits for stroke/transient ischemic attack, heart failure or hypertension at 6-months post-recall. Cox proportional hazard models with propensity score weighting compared the risk of outcomes between groups. RESULTS: Of the 87 130 adherent patients, 15% were valsartan users and 85% were users of non-recalled ARBs/ACE-Is. Valsartan use was not associated with an increased risk of all-cause hospitalization/ED/UC use six-months post-recall (HR 1.00; 95% CI 0.96-1.03), compared with individuals taking non-recalled ARBs/ACE-Is. Similarly, cardiac events 6-months post-recall did not differ between individuals on valsartan and non-recalled ARBs/ACE-Is (HR 1.04; 95% CI 0.97-1.12). CONCLUSIONS: The valsartan recall did not affect short-term outcomes of heart failure patients. However, the recall potentially disrupted the medication regimens of patients, possibly straining the healthcare system.


Assuntos
Inibidores da Enzima Conversora de Angiotensina , Insuficiência Cardíaca , Humanos , Idoso , Estados Unidos , Valsartana/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/efeitos adversos , Antagonistas de Receptores de Angiotensina/efeitos adversos , Bloqueadores do Receptor Tipo 1 de Angiotensina II/efeitos adversos , Estudos de Coortes , Medicare , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/induzido quimicamente , Tetrazóis/efeitos adversos
3.
J Am Heart Assoc ; 13(1): e032266, 2024 Jan 02.
Artigo em Inglês | MEDLINE | ID: mdl-38156554

RESUMO

BACKGROUND: Valsartan was recalled by the US Food and Drug Administration in July 2018 for carcinogenic impurities, resulting in a drug shortage and management challenges for valsartan users. The influence of the valsartan recall on clinical outcomes is unknown. We compared the risk of adverse events between hypertensive patients using valsartan and a propensity score-matched group using nonrecalled angiotensin receptor blockers and angiotensin-converting enzyme inhibitors. METHODS AND RESULTS: We used Optum's deidentified Clinformatics Datamart (July 2017-January 2019). Hypertensive patients who received valsartan or nonrecalled angiotensin receptor blockers/angiotensin-converting enzyme inhibitors for 1 year before and on the recall date were compared. Primary outcomes were measured in the 6 months following the recall and included: (1) a composite measure of all-cause hospitalization, all-cause emergency department visit, and all-cause urgent care visit, and (2) a composite cardiac event measure of hospitalizations for acute myocardial infarction and hospitalizations/emergency department visits/urgent care visits for stroke/transient ischemic attack, heart failure, or hypertension. We compared the risk of outcomes between treatment groups using Cox proportional hazard models. Of the hypertensive patients, 76 934 received valsartan, and 509 472 received a nonrecalled angiotensin receptor blocker/angiotensin-converting enzyme inhibitor. Valsartan use at the time of recall was associated with a higher risk of all-cause hospitalization, emergency department use, or urgent care use (hazard ratio [HR], 1.02 [95% CI, 1.00-1.04]) and the composite of cardiac events (HR, 1.22 [95% CI, 1.15-1.29]) within 6 months after the recall. CONCLUSIONS: The valsartan recall and shortage affected hypertensive patients. Local- and national-level systems need to be enhanced to protect patients from drug shortages by providing safe and reliable medication alternatives.


Assuntos
Insuficiência Cardíaca , Hipertensão , Humanos , Antagonistas de Receptores de Angiotensina/efeitos adversos , Estudos Retrospectivos , Tetrazóis/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/efeitos adversos , Valsartana/uso terapêutico , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Hipertensão/induzido quimicamente , Compostos de Bifenilo/uso terapêutico
4.
J Manag Care Spec Pharm ; 29(10): 1158-1164, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37776114

RESUMO

BACKGROUND: Medication costs for antidiabetic drugs have risen significantly in the United States, causing concerns about the affordability of these essential treatments. OBJECTIVE: To examine out-of-pocket spending for antidiabetic medication and evaluate what proportion of Americans reach catastrophic spending levels during the year. METHODS: This retrospective cohort analysis of nationally representative data from the 2020 Medical Expenditure Panel Survey (MEPS) was analyzed for respondents that reported a diabetes diagnosis. Prescription drug costs were identified from the MEPS Prescribed Medicines File, which included both total prescription payment and out-of-pocket payment for each medication fill. Catastrophic spending thresholds were evaluated based on the World Health Organization's definition, which is spending greater than 40% of a household's nonsubsistence income on health care payments. Statistical analysis was performed with Stata 17 and sample weights were applied adjusting for the MEPS complex survey design to produce national estimates. Descriptive statistics were reported as weighted counts and percentages for categorical variables and as medians with interquartile range for continuous variables. Comparisons of reaching catastrophic spending thresholds across study variables were evaluated with Pearson chi-square tests. A P value less than 0.05 was considered statistically significant in this study. RESULTS: The study included data from a weighted US population of 29.5 million Americans with diabetes. Among this group, 23.8 million (81%) reported use of a prescription medication to treat diabetes. Total reported out-of-pocket payments paid by the patient for antidiabetic medication surpassed $5.2 billion with the largest portion attributable to the insulin subclass, which accounted for 42% or $2.2 billion. The data suggest an estimated 3 million Americans (10.3%) experienced out-of-pocket spending for antidiabetic drugs that reached catastrophic spending thresholds in 2020. CONCLUSIONS: Affordability of prescribed medication in community-dwelling persons with diabetes remains a significant challenge for many Americans.


Assuntos
Diabetes Mellitus , Medicamentos sob Prescrição , Humanos , Estados Unidos , Estudos Retrospectivos , Prevalência , Custos e Análise de Custo , Gastos em Saúde , Hipoglicemiantes
5.
Mil Med ; 178(11): 1241-4, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-24183773

RESUMO

OBJECTIVE: Describe a patient safety program designed to decrease use of transdermal fentanyl (TF) among opioid-naïve patients in the U.S. Military Health System (MHS). METHODS: The program automatically reviewed patient profiles for prior strong opioid use when starting treatment with TF. New prescriptions for TF among users without a prior strong opioid generated a rejection message indicating that the patient may not be opioid tolerant and stopped the fill. However, pharmacists could override the rejection. We collected pharmacy claims data to measure the use of TF among seemingly opioid-naïve patients following implementation of the program in August 2007. RESULTS: During the first 10 months, 26,366 patients attempted to fill TF prescriptions in the MHS; 10,025 patients (38%) encountered a claim rejection, with a warning message advising the pharmacist to verify opioid tolerance. The majority of rejection messages were overridden by the pharmacist; however, 1,402 patients did not receive a TF prescription following the rejection, representing a 14% decrease in TF claims dispensed to patients who appeared opioid naïve in the MHS. CONCLUSION: A patient safety program with targeted pharmacy messaging reduced TF use among seemingly opioid-naïve patients in the MHS without disrupting treatment for patients whose rejections were overridden.


Assuntos
Automação , Tolerância a Medicamentos , Fentanila , Medicina Militar/métodos , Transtornos Relacionados ao Uso de Opioides/diagnóstico , Administração Cutânea , Adulto , Analgésicos Opioides/administração & dosagem , Feminino , Fentanila/administração & dosagem , Seguimentos , Humanos , Masculino , Militares , Estudos Prospectivos , Estados Unidos
6.
J Manag Care Pharm ; 16(8): 578-92, 2010 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-20866163

RESUMO

BACKGROUND: Like many payers, the Department of Defense (DoD) has limited ability to work directly with prescribers to ensure appropriate medication use. Many older beneficiaries are prescribed multiple maintenance medications, placing them at higher risk for adverse drug interactions, contraindicated medication use, and other polypharmacy-related problems. Medication reviews may mitigate these risks, but the optimal venue for medication therapy management is unclear. OBJECTIVES: To (a) determine if beneficiaries will respond to a mailed request from the DoD to pursue a medication review; (b) identify medication review location and outcomes from the patient perspective; and (c) assess the statistical significance of changes in the number of prescription medications overall and for key categories, including maintenance medications and contraindicated medications, relative to a propensity-matched comparison group. METHODS: A total of 4,000 TRICARE beneficiaries aged 55 years or older, residing in North Carolina, who obtained 10 or more maintenance medications (defined by a unique combination of drug, strength, and dosage form) during the 90-day baseline period from May 3, 2008, to July 31, 2008, were mailed letters requesting their participation in the study. Consenting subjects received a personalized medication list to review with their physicians or pharmacists and a survey form to complete after the review. Survey results were compared by location of medication review (i.e., physician's office, pharmacy, or both). Changes from the 90-day baseline to 90-day post-intervention period were calculated for prescription utilization measures (total drug count, maintenance drug count, count of Beers list medications, and count of contraindicated drug combinations) for the subsample of subjects who completed the survey (n = 373) and for subjects who received the initial consent letter (n = 3,856) versus a propensity-matched comparison sample drawn from neighboring states. Variables included in the propensity score were gender, age group, military rank, catchment status indicating proximity to military pharmacies, enrollment status, number of pharmacy settings used, and each of 30 binary disease indicators. RESULTS: A total of 1,469 subjects responded to the consent letter (response rate = 38.1%); 606 subjects consented to participate (consent rate = 15.7%); and 373 subjects returned a completed survey (completion rate = 9.7%). Among those who completed the survey, 190 (50.9%) received reviews in a physician's office; 103 (27.6%) received reviews in a pharmacy; 60 (16.1%) received reviews in both locations; and 20 (5.4%) reported a different location or no location. 61 survey respondents (16.4%) indicated that they were told to stop a medication, and 77 (20.6%) reported a dosage change. Medication changes occurred significantly more frequently for reviews performed at a physician's office compared with other review locations. Therapeutic classes most frequently stopped or adjusted for dosage were antidiabetics, diuretics, antilipidemics, renin-angiotensin aldosterone system inhibitors, anticoagulants, nonsteroidal anti-inflammatory drugs, and beta-adrenergic blocking agents. 85% of respondents reported that the medication review was worth doing. In the assessments of changes in prescription utilization from the baseline to post-intervention periods, no significant by-group differences were noted among those who completed the study relative to their matched comparison subjects. In the comparison of subjects who received the initial consent letter with their matched counterparts, small but statistically significant differences were observed for several prescription utilization measures, including changes in use of high-risk Beers list medications (P = 0.033); use of electrolytic, caloric, and water balance medications (P = 0.038); and use of hypertension medications (P = 0.028). The magnitude of the decrease observed among comparison subjects, however, exceeded that observed among the case subjects. CONCLUSIONS: Response was poor to a mailing that promoted a beneficiary- initiated medication review. The absence of significant changes following the medication review suggests several possibilities: a mailed intervention is ineffective in promoting medication review; medication regimens for study subjects are already optimized to the extent obtainable through a routine medication review; or the study sample size was too small to detect relevant changes. Most drug regimen changes were dosage adjustments for current medications or substitutions within the same therapeutic class. The extent to which comprehensive assessment of a patient's medication regimen, including nonprescription and herbal agents, was performed is unclear. More intensive interventions may be required to ensure that medication regimens are being actively managed among those who use a large number of prescription medications.


Assuntos
Tratamento Farmacológico/métodos , Conduta do Tratamento Medicamentoso , Educação de Pacientes como Assunto/métodos , Fatores Etários , Idoso , Área Programática de Saúde , Interpretação Estatística de Dados , Prescrições de Medicamentos , Feminino , Humanos , Masculino , Prontuários Médicos , Pessoa de Meia-Idade , Militares , North Carolina , Avaliação de Resultados em Cuidados de Saúde , Aceitação pelo Paciente de Cuidados de Saúde , Farmacêuticos , Polimedicação , Serviços Postais , Medicina de Precisão , Fatores Sexuais , Estados Unidos , United States Department of Defense
7.
Mil Med ; 174(9): 958-63, 2009 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-19780372

RESUMO

OBJECTIVE: Examine trends in U.S. Department of Defense (DoD) outpatient drug spending and utilization between 2002 and 2007. METHODS: We analyzed pharmacy claims data from the U.S. Military Health System (MHS), using a cross-sectional analysis at the prescription and patient-year level and measuring utilization in 30-day equivalent prescriptions and expenditures in dollars. RESULTS: Pharmaceutical spending more than doubled in DoD, from $3 billion in FY02 to $6.5 billion in FY07. The largest increase occurred in the DoD community pharmacy network, where utilization grew from 6 million 30-day equivalent prescriptions in the first quarter of FY02 to more than 16 million in the last quarter of FY07. The smallest increase in annual spending occurred in FY07 (5.5%), down from a high of 27.5% in FY03. CONCLUSIONS: The MHS has experienced rapid growth in pharmaceutical spending since FY02. However, there are signs that growth in pharmaceutical spending may be slowing.


Assuntos
Custos de Medicamentos/tendências , Prescrições de Medicamentos/economia , Revisão de Uso de Medicamentos , Militares , Estudos Transversais , Humanos , Estados Unidos
8.
Pharmacoepidemiol Drug Saf ; 18(10): 891-9, 2009 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-19634117

RESUMO

PURPOSE: To evaluate the use of lipid-lowering treatment (LLT) among patients at risk for cardiovascular disease (CVD) in the US Military Health System (MHS). METHODS: The study examined healthcare service and prescription records among beneficiaries > or =18 years for calendar years 2002, 2004, and 2006. Patients were categorized based on cardiovascular (CV) risk, with exposure to LLT defined as one or more prescriptions for lipid-lowering medication. Logistic regression models estimated odds of treatment in 2004 and 2006 relative to 2002 after adjustment for age, gender, and CV risk. RESULTS: The yearly unadjusted population prevalence of LLT increased from 9.3% in 2002 to 14.7% in 2006. Among subjects with the highest CV risk, established coronary artery disease (CAD) or peripheral vascular disease (PVD), those receiving LLT increased from 55% in 2002 to 65% in 2006 (adjusted OR = 1.50, 95% CI 1.48, 1.52, p < 0.00). Treatment rates among diabetic patients with no coded CAD or PVD showed the largest relative increase from 47% in 2002 to 66% in 2006 (adjusted OR = 2.30, 95% CI 2.26, 2.332, p < 0.00). LLT growth was lowest among those with only 1 coded CV risk factor (adjusted OR = 1.32, 95% CI 1.31, 1.34, p < 0.00). CONCLUSIONS: The MHS experienced a significant increase in LLT among patients at greatest risk for cardiovascular disease. However, treatment may still be underutilized as approximately one-third of high-risk patients did not receive lipid-lowering medication.


Assuntos
Doenças Cardiovasculares/prevenção & controle , Dislipidemias/tratamento farmacológico , Hipolipemiantes/uso terapêutico , Seguro Saúde , Medicina Militar , Padrões de Prática Médica , Adolescente , Adulto , Doenças Cardiovasculares/etiologia , Prescrições de Medicamentos , Uso de Medicamentos , Dislipidemias/complicações , Feminino , Fidelidade a Diretrizes , Humanos , Seguro Saúde/estatística & dados numéricos , Seguro de Serviços Farmacêuticos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Medicina Militar/estatística & dados numéricos , Razão de Chances , Vigilância da População , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/estatística & dados numéricos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Estados Unidos , Adulto Jovem
9.
J Manag Care Pharm ; 15(2): 133-46, 2009 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-19236127

RESUMO

BACKGROUND: The U.S. Department of Defense (DoD) health care benefit (TRICARE) provides 9.2 million active-duty and retired uniformed services personnel and their family members with access to a comprehensive pharmacy benefit with low out-of-pocket costs. DoD's Uniform Formulary is available worldwide at DoD's 3 pharmacy points of service (military pharmacies, contracted mail order, and community [network and non-network] pharmacies). Community pharmacies, military pharmacies, and mail order accounted for 64%, 23%, and 13%, respectively, of DoD's $6.5 billion total drug expenditures during fiscal year (FY) 2007 (October 1, 2006, through September 30, 2007). OBJECTIVE: To describe the DoD formulary management process and estimate cost savings associated with implementation of DoD's 3-tier formulary. SUMMARY: DoD implemented its 3-tier Uniform Formulary in 2005. This implementation required the development of a transparent formulary management process that (a) assesses medications for formulary status based on an evidence-based clinical evaluation and assessment of relative cost-effectiveness using pharmacoeconomic and budget impact modeling, (b) allows open and equitable price competition among pharmaceutical manufacturers based on formulary status, and (c) provides a public forum for beneficiaries and beneficiary organizations to comment on formulary changes. Through April 16, 2008, Uniform Formulary decisions had been implemented in 32 drug classes representing 53% of FY 2007 total drug expenditures. The 32 classes containing 343 drugs were reviewed at 12 quarterly meetings of the DoD Pharmacy and Therapeutics (P&T) Committee and the Beneficiary Advisory Panel, resulting in the classification of 85 drugs (24.8%) in tier 3, 92 drugs (26.8%) in tier 2, and 166 drugs (48.4%) in tier 1. Implementation of the 3-tier formulary was associated with an estimated $926 million in cost avoidance in FY 2007, primarily due to price reductions at military pharmacies and mail order, tier 3 copayments at community pharmacies and mail order, and change in product mix and pharmacy type (point of service). An additional $60 million in rebates were obtained in FY 2007 through the Voluntary Agreements for TRICARE Retail Pharmacy Refunds (UF VARR) program for prescriptions filled at community pharmacies; the UF VARR program first became available for drug classes reviewed in August 2006. The total of $986 million in cost avoidance and rebates represents an approximate 13% reduction, compared with what DoD otherwise would have paid in FY 2007 ($7.5 billion, compared with actual drug expenditures of $6.5 billion). CONCLUSION: As in most private-sector health plans, the DoD formulary management process (a) includes rigorous decision making that is informed by clinical literature evaluations and pharmacoeconomic analyses, (b) results in drug formulary changes that require considerable effort in communication with providers and beneficiaries, and (c) produces drug cost savings derived from increased price competition among drug manufacturers. Unlike private sector health plans, the DoD uses more disclosure of the results of evaluation of the evidence, solicits provider opinions before P&T committee deliberation, and provides the opportunity for beneficiaries to have input before implementation of formulary changes.


Assuntos
Formulários Farmacêuticos como Assunto , Programas de Assistência Gerenciada/organização & administração , Medicina Militar/organização & administração , Redução de Custos/métodos , Tomada de Decisões , Custos de Medicamentos , Farmacoeconomia , Humanos , Seguro de Serviços Farmacêuticos/economia , Programas de Assistência Gerenciada/economia , Medicina Militar/economia , Comitê de Farmácia e Terapêutica/organização & administração , Estados Unidos
10.
J Am Pharm Assoc (2003) ; 47(3): 410-4, 2007.
Artigo em Inglês | MEDLINE | ID: mdl-17510039

RESUMO

OBJECTIVE: To describe challenges and opportunities to the profession of pharmacy associated with the emergence of pharmacy-based medical clinics. SUMMARY: Pharmacy-based medical clinics have emerged as a convenient, low-cost treatment option for many patients. These clinics, which are staffed by physicians' assistants or nurse practitioners, often are located directly within community pharmacies and offer rapid diagnosis and treatment for a limited number of health problems. With plans for significant expansion of these clinics, the profession of pharmacy faces a number of challenges. Allocating space in community pharmacies for medical clinics could place pharmacists at a disadvantage to other providers as they pursue ancillary health care activities. However, these clinics also represent an opportunity for pharmacists to position themselves as legitimized health care providers who are reimbursed for the consultative services they perform. Because most conditions diagnosed at pharmacy-based medical clinics have well-established treatment protocols, pharmacists would be well positioned to provide these services under collaborative practice agreements. This could ultimately provide the resources and payment structure necessary for pharmacists to provide other types of patient care services, including medication therapy management (MTM). CONCLUSION: As pharmacy-based clinics continue to proliferate, pharmacists should carefully consider surrendering space in community pharmacies to other health care practitioners. These clinics present pharmacists with an opportunity to provide many of the additional health care services for which we have so vigorously argued. Failure to respond to the acute care needs of patients today may present pharmacists with a significant barrier as they continue to expand into direct patient care activities.


Assuntos
Instituições de Assistência Ambulatorial , Serviços Comunitários de Farmácia , Farmacêuticos , Papel Profissional , Estados Unidos , Recursos Humanos
11.
J Headache Pain ; 8(2): 105-13, 2007 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-17497263

RESUMO

The economic benefits of daily migraine prevention have been subject to ongoing debate. This study was undertaken to determine if the initiation of prevention had an observable effect on ambulatory health care utilisation when compared to acute migraine treatment alone. Administrative claims data from the Military Health System were used to conduct a retrospective, longitudinal cohort study of 3762 patients with migraine. New users of daily migraine prevention were matched to a reference group of non-users using propensity score methods. This matched sample then was used to evaluate the effect of prevention on ambulatory health care expenditures. The study results showed that exposure to daily migraine prevention led to lower rates of utilisation relative to what new patients would have consumed in the absence of treatment. The results suggest that additional economic benefits could be realised by increasing the appropriate use of daily migraine prevention.


Assuntos
Atenção à Saúde/estatística & dados numéricos , Revisão da Utilização de Seguros , Transtornos de Enxaqueca/economia , Transtornos de Enxaqueca/prevenção & controle , Adulto , Estudos de Casos e Controles , Estudos de Coortes , Feminino , Humanos , Masculino , Transtornos de Enxaqueca/epidemiologia , Reprodutibilidade dos Testes
12.
J Am Pharm Assoc (2003) ; 46(2): 193-201; quiz 202-4, 2006.
Artigo em Inglês | MEDLINE | ID: mdl-16602229

RESUMO

OBJECTIVE: To describe the implications of a follow-on biologic approval process with focus on current stakeholders, implications of the status quo, and recommendations for future policy. DATA SOURCES: A search using Medline, International Pharmaceutical Abstracts, Med Ad News, F-D-C Reports/Pink Sheets, and Google index directories was conducted with terms such as biologic, biopharmaceutical, generic, and follow-on. STUDY SELECTION: Articles pertaining to the follow-on biologic debate. DATA EXTRACTION: By the authors. DATA SYNTHESIS: Over the past decade, the biopharmaceutical market has experienced substantial growth in the number of product approvals and sales. In contrast with prescription medications, biologic agents currently lack an abbreviated regulatory approval process. Evidence from the Drug Price Competition and Patent Term Restoration Act of 1984 suggests that reducing barriers to generic competition in the pharmaceutical market successfully increases generic market penetration and reduces overall prices to consumers. Although scientific and regulatory dissimilarities between biopharmaceuticals and other medications exist, a follow-on biologic approval process has the potential to play an important role in containing growth in pharmaceutical spending. In addition to biopharmaceutical and generic biopharmaceutical manufacturers, stakeholders with a vested interest in this debate include individual consumers who continue to bear the burden of spending increases in the pharmaceutical market. CONCLUSION: The debate over a follow-on process likely will be difficult as parties seek a balance between incentives for biopharmaceutical innovation, consumer safety, and affordability of existing biologic products.


Assuntos
Aprovação de Drogas/legislação & jurisprudência , Indústria Farmacêutica/tendências , Medicamentos Genéricos/economia , Biofarmácia/economia , Biofarmácia/tendências , Aprovação de Drogas/estatística & dados numéricos , Indústria Farmacêutica/economia , Medicamentos Genéricos/farmacocinética , Competição Econômica , Humanos , Equivalência Terapêutica , Estados Unidos
13.
Am J Manag Care ; 12(2): 110-9, 2006 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-16464140

RESUMO

OBJECTIVE: To compare the performance of the Elixhauser, Charlson, and RxRisk-V comorbidity indices and several simple count measurements, including counts of prescriptions, physician visits, hospital claims, unique prescription classes, and diagnosis clusters. STUDY DESIGN: Each measurement was calculated using claims data during a 1-year period before the initial filling of an antihypertensive medication among 20 378 members of a managed care organization. The primary outcome variable was the log-transformed sum of prescription, physician, and hospital expenditures in the year following the prescription encounter. METHODS: In addition to descriptive statistics and Spearman rank correlations between measurements, the predictive performance was determined using linear regression models and corresponding adjusted R(2) statistics. RESULTS: The Charlson index and the Elixhauser index performed similarly (adjusted R(2) = 0.1172 and 0.1148, respectively), while the prescription claims-based RxRisk-V (adjusted R(2) = 0.1573) outperformed both. An age- and gender-adjusted regression model that included a count of diagnosis clusters was the best individual predictor of payments (adjusted R(2) = 0.1814). This outperformed age- and gender-adjusted models of the number of unique prescriptions filled (adjusted R(2) = 0.1669), number of prescriptions filled (R(2) = 0.1573), number of physician visits (adjusted R(2) = 0.1546), logtransformed prior healthcare payments (adjusted R(2) = 0.1359), and number of hospital claims (adjusted R(2) = 0.1115). CONCLUSION: Simple count measurements appear to be better predictors of future expenditures than the comorbidity indices, with a count of diagnosis clusters being the single best predictor of future expenditures among the measurements examined.


Assuntos
Comorbidade , Gastos em Saúde , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Previsões , Humanos , Masculino , Pessoa de Meia-Idade , Estados Unidos
14.
Headache ; 45(9): 1171-80, 2005 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-16178947

RESUMO

OBJECTIVE: The primary objectives were to examine national trends of prescription medication use for headache and explore patterns of variation in the use of these medications across social and demographic levels. BACKGROUND: Despite widespread use of prescription medication for management of headache, little is known about utilization patterns or patient characteristics associated with receiving this type of treatment. METHODS: This study conducted a secondary analysis of data obtained during the 2000 Medical Expenditure Panel Survey, a representative survey of the U.S. noninstitutionalized population. Weighted descriptive statistics and logistic regression models were used to evaluate patterns and rates of overall prescription medication use in patients reporting headache as a household condition. RESULTS: An estimated 9.7 million people 18 years or older reported suffering from headache in 2000. Of these, 46% reported using at least one medication for the treatment of headache. Migraine-specific abortive medication (ie, selective serotonin receptor agonists and ergotamine derivatives) was the most frequently reported medication class, used by 36% of participants. Opiate analgesics and butalbital-containing products also experienced extensive prescribing reported by 22% and 17% of survey respondents, respectively. After adjustment for covariates, wide variation in the use of prescription medication was observed across sociodemographic characteristics including age, ethnicity, and insurance status. CONCLUSION: The observed variation in prescription medication use by drug class and sociodemographic characteristics suggests strategies are needed for improving current prescribing patterns in this patient population.


Assuntos
Prescrições de Medicamentos/estatística & dados numéricos , Revisão de Uso de Medicamentos/estatística & dados numéricos , Cefaleia/tratamento farmacológico , Transtornos de Enxaqueca/tratamento farmacológico , Padrões de Prática Médica/estatística & dados numéricos , Adulto , Idoso , Analgésicos/uso terapêutico , Prescrições de Medicamentos/economia , Feminino , Cefaleia/epidemiologia , Pesquisas sobre Atenção à Saúde , Gastos em Saúde/estatística & dados numéricos , Gastos em Saúde/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Transtornos de Enxaqueca/epidemiologia , Agonistas do Receptor de Serotonina/uso terapêutico , Estados Unidos/epidemiologia
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